FDAClass IIMay 26, 2021

REF 7617405 recall

REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when…

Why was REF 7617405 recalled?

Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No. reds4650 redt0780 redt1528 redt4250 redu0070 redu0706 redu1526 REDU2456 redv1194 REDV1893 redv1894 redv2160 REDV2537 redv2538 redv2539 redv2924 redv4016 REDW0575 redw0837 redw4033 redw4034 redw4035 redw4036 redw4037 redw4038 REDW4039 redw4040 redw4042 redw4164 redw4170 redx0604 redx0743 redx0972 redx0973 redx0974 redx0975 redx0976 redx0977 redx0978 redx0979 redx0980 redx0991 redx0992 redx0993 redx0994 redx0995 redx0996 redx1339 redx1340 redx1504 redx2371 redx2483 redx4877 redy0094 redy0106 redy0107 redy0662 redy0713 redy1680 REDY2962 redz0056 redz0185 redz0664 redz0697 redz1649 redz1710 REEN1131 reen1240 reen1911 reen1982

Product
REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when…
Recalling firm
Bard Access Systems Inc.
Quantity
N/A
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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